CHICAGO (STMW) – A now-suspended psychiatrist pleaded guilty Friday to taking kickbacks and benefits worth nearly $600,000 from pharmaceutical companies for prescribing an anti-psychotic drug to thousands of elderly and mentally ill patients.
In addition to the guilty plea, 71-year-old Michael Reinstein agreed to pay the U.S. and Illinois governments $3.79 million to settle a civil lawsuit connected to the scheme, according to a statement from the U.S. Attorney’s office. The suit alleged the doctor submitted at least 140,000 false Medicare and Medicaid claims for prescriptions of the anti-psychotic clozapine.
Prosecutors said Reinstein routinely prescribed clozapine to thousands of elderly and mentally ill patients in more than 30 area nursing homes and other facilities between August 2003 and July 2011.
Clozapine is used to treat schizophrenia, but typically only as a “last resort” because of possible side effects, including inflammation of heart muscle, a potentially deadly decrease in white blood cells, and increased mortality in elderly patients, according to the U.S. Attorney’s office.
Reinstein took kickbacks from drug companies in the form of speaking and consulting agreements worth up to $50,000 a year, in addition to free meals, tickets to sporting events and an all-expense-paid trip to Miami, prosecutors said. He was also paid to conduct research studies related to the drug.
Teva Pharmaceuticals USA and IVAX Pharmaceuticals paid $27.6 million to settle allegations they violated the state and federal False Claims acts by making payments to Reinstein in exchange for prescriptions, the U.S. Attorney’s office said.
Reinstein’s plea agreement calls for the government to recommend a sentence of 18.5 months in prison when he is sentenced by U.S. District Judge Sharon Johnson, prosecutors said. Under the civil settlement, he must pay the federal government $1,837,968 and the state $1,956,741 within 10 days.
Records from the Illinois Department of Financial and Professional Regulation list Reinstein’s medical license as “suspended” as of August 2014.
If you or someone in your household is allergic to milk, take heed: a recent study by the Food and Drug Administration (FDA) tested 100 dark chocolate products and found that many contained milk. More importantly, you can’t always tell that’s the case simply by reading the food label.
Milk is one of eight major food allergens (the others are wheat, eggs, peanuts, tree nuts, fish, Crustacean shellfish and soybeans). U.S. law requires foods containing a major food allergen to provide its name—in this case, milk—on the label. This is one of the ways to help ensure consumers know what’s in the food they’re eating. Undeclared (not listed on the label) allergens are a leading cause of food recall requests by the FDA.
From September 2009 to September 2012, about one-third of foods reported to FDA as serious health risks involved undeclared allergens. The five food types most often involved in food allergen recalls were bakery products, snack foods, candy, dairy products and dressings. Within the candy category, there were many reports of undeclared milk in dark chocolate.
A manufacturer may not intend to use milk in a dark chocolate product, Bedford says. But if the dark chocolate product shares equipment with, for example, a milk chocolate product, traces of milk may inadvertently wind up in the dark chocolate. After hearing from consumers who had eaten dark chocolate and experienced harmful reactions, FDA tested 100 dark chocolate bars for the presence of undeclared milk. The selected bars were obtained from different parts of the U.S. and each bar was unique in terms of product line and/or manufacturer.
“We divided the bars into categories based on the statements on the labels,” Bedford explains. The categories included precautionary statements such as “may contain milk” or “may contain traces of milk”; statements such as “dairy-free” or “allergen-free”; no mention of milk on the label; and inconsistent statements.
Even a consumer who carefully reads the label may be confused by a statement such as “vegan” (which implies that no animal-derived products were used) along with a precautionary statement referring to the presence of milk, Bedford says. Moreover, a consumer will not know how much or whether milk is present when a product is labeled “may contain traces of milk,” or when the product was manufactured with the same equipment used for products containing milk.
“First of all, milk-allergic consumers should be aware that a high proportion of the dark chocolates we tested contained milk, even when the label failed to list milk as an ingredient,” Bedford says. Of greatest concern are chocolate samples that have no statement regarding milk on the label or have inconsistencies in the label. Several of the chocolates labeled “dairy free” were also found to contain milk.
While dark chocolates labeled “dairy free or allergen-free” were the least likely to contain milk, two out of 17 of these products were found to contain milk.
All seven bars that declared the presence of milk on the label contained milk; however, 55 (59%) of 93 bars without any clear indication of the presence of milk also were found to contain milk.
Six out of the eleven chocolate products labeled “traces of milk” contained milk at detectable levels high enough to potentially cause severe reactions in some individuals.